Eli Lil­ly picks up an­oth­er Covid-19 EUA as reg­u­la­tors wave through its Olu­mi­ant plus remde­sivir com­bo

Eli Lil­ly has picked up an­oth­er win at the FDA, cross­ing the fin­ish line again in the Covid-19 treat­ment race de­spite some mixed da­ta. And the au­tho­riza­tion comes be­fore Re­gen­eron’s an­ti­body ther­a­py, which no­tably was used to treat Pres­i­dent Don­ald Trump back in Oc­to­ber, could pick up an EUA.

Reg­u­la­tors have giv­en the green light to Lil­ly’s Olu­mi­ant, in com­bi­na­tion with Gilead’s remde­sivir, to treat sus­pect­ed or con­firmed Covid-19 cas­es in both hos­pi­tal­ized adults and chil­dren over 2 that need sup­ple­men­tal oxy­gen, ven­ti­la­tors or life sup­port. The au­tho­riza­tion was based on da­ta show­ing the me­di­an time to re­cov­ery from Covid-19 was sev­en days on the com­bo vs. eight days for remde­sivir by it­self.

“Based on the FDA’s re­view of the to­tal­i­ty of the sci­en­tif­ic ev­i­dence avail­able, the agency has de­ter­mined that it is rea­son­able to be­lieve that baric­i­tinib, in com­bi­na­tion with remde­sivir, may be ef­fec­tive in treat­ing Covid-19 for the au­tho­rized pop­u­la­tion,” the FDA said in a state­ment.

A Lil­ly spokesper­son con­firmed to End­points News that the cock­tail will cost hos­pi­tals $150 per pa­tient per day for those with in­sur­ance.

Lil­ly re­vealed the da­ta back in Sep­tem­ber, defin­ing re­cov­ery as meet­ing the cri­te­ria for hos­pi­tal dis­charge. They fol­lowed up in Oc­to­ber say­ing the p-val­ue was 0.047, with the ben­e­fits be­ing most pro­nounced among pa­tients need­ing sup­ple­men­tal oxy­gen or non-in­va­sive ven­ti­la­tion at base­line.

The EUA comes amid broad­er ques­tions re­gard­ing remde­sivir’s ef­fec­tive­ness. No­tably, a WHO tri­al showed the an­tivi­ral didn’t have any sub­stan­tial ef­fect on im­prov­ing mor­tal­i­ty rates, re­duc­ing the amount of pa­tients need­ing ven­ti­la­tors or short­en­ing hos­pi­tal stays.

The FDA is­sued a full ap­proval for remde­sivir in late Oc­to­ber on the ba­sis of a sep­a­rate tri­al, where the drug had “mod­er­ate­ly re­duced time to re­cov­ery.” That study, the NI­AID-spon­sored Phase III ACTT-1 tri­al pub­lished on Oct 8, demon­strat­ed a re­duc­tion in re­cov­ery time by five days in hos­pi­tal­ized Covid-19 pa­tients and by sev­en days in pa­tients re­quir­ing oxy­gen.

Reg­u­la­tors did con­sid­er the WHO tri­al in its de­ci­sion to ap­prove remde­sivir, but said since Gilead’s ACTT-1 study was ran­dom­ized, dou­ble-blind­ed and place­bo-con­trolled where­as the WHO tri­al was open-la­bel, they found ACTT-1 to be “bet­ter suit­ed” in a time to re­cov­ery end­point.

Olu­mi­ant, al­so known as baric­i­tinib, is a JAK in­hibitor used to treat rheuma­toid arthri­tis, net­ting Eli Lil­ly near­ly $450 mil­lion through the first three quar­ters of 2020. It was the first drug the NIH test­ed in com­bi­na­tion im­me­di­ate­ly af­ter fin­ish­ing the remde­sivir tri­al.

This is the sec­ond EUA Lil­ly has re­ceived in as many weeks, with reg­u­la­tors au­tho­riz­ing one of the com­pa­ny’s neu­tral­iz­ing an­ti­body treat­ments less than ten days ago. Both Lil­ly and Re­gen­eron, which is de­vel­op­ing its own an­ti­body treat­ment, re­vealed they ap­plied for those EUAs on the same day.

Qual­i­ty Con­trol in Cell and Gene Ther­a­py – What’s Re­al­ly at Stake?

In early 2021, Bluebird Bio was forced to suspend clinical trials of its gene therapy for sickle cell disease after two patients in the trial developed cancer. As company scientists rushed to assess whether there was any causal link between the therapy and the cancer cases, Bluebird’s stock value plummeted – as did those of multiple other biopharma companies developing similar therapies.

While investigations concluded that the gene therapy was unlikely to have caused cancer, investors and the public may be more skittish regarding the safety of gene and cell therapies after this episode. This recent example highlights how delicate the fields of cell and gene therapy remain today, even as they show great promise.

Covid-19 man­u­fac­tur­ing roundup: Mary­land looks to grow biotech ca­pac­i­ty with $400M check; Rus­sia lands sec­ond Sput­nik V part­ner this week

A Maryland real estate project has added three new biotech-focused manufacturing and research buildings to an office park to keep up with demand created by the pandemic, the Washington Business Journal reported.

The Milestone Business Park — located off of I-270 in Germantown, MD — will see the new buildings and a total of 532,000 square feet as the campus rebrands to Milestone Innovation Park.

Novavax CEO Stanley Erck at the White House in 2020 (Andrew Harnik, AP Images)

As fears mount over J&J and As­traZeneca, No­vavax en­ters a shaky spot­light

As concerns rise around the J&J and AstraZeneca vaccines, global attention is increasingly turning to the little, 33-year-old, productless, bankruptcy-flirting biotech that could: Novavax.

In the now 16-month race to develop and deploy Covid-19 vaccines, Novavax has at times seemed like the pandemic’s most unsuspecting frontrunner and at times like an overhyped also-ran. Although they started the pandemic with only enough cash to last 6 months, they leveraged old connections and believers into $2 billion and emerged last summer with data experts said surpassed Pfizer and Moderna. They unveiled plans to quickly scale to 2 billion doses. Then they couldn’t even make enough material to run their US trial and watched four other companies beat them to the finish line.

Law pro­fes­sors call for FDA to dis­close all safe­ty and ef­fi­ca­cy da­ta for drugs

Back in early 2018 when Scott Gottlieb led the FDA, there was a moment when the agency seemed poised to release redacted complete response letters and other previously undisclosed data. But that initiative never gained steam.

Now, a growing chorus of researchers are finding that a dearth of public data on clinical trials and pharmaceuticals means industry and the FDA cannot be held accountable, two law professors from Yale and New York University write in an article published Wednesday in the California Law Review.

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In a sup­ply chain short­age workaround, Aus­trali­a's Vic­to­ria state aims to build its own mR­NA fa­cil­i­ty

As countries all around the world have experienced troubles with vaccine shortages, Australia’s Victoria state is developing its own mRNA manufacturing facility in an effort to up its number of vaccinated residents.

Victoria will spend $39 million to set up the facility, which could be the first in the southern hemisphere, Reuters reported. The mRNA technology is used in the Pfizer-BioNTech and Moderna vaccines, and has gotten more attention, as adenovirus-based vaccines from AstraZeneca and J&J have had reports of rare, but similar blood clots in some patients. There have been no reports of major side effects in either Moderna or Pfizer’s jab.

FDA of­fers scathing re­view of Emer­gent plan­t's san­i­tary con­di­tions, em­ploy­ee train­ing af­ter halt­ing pro­duc­tion

The FDA wrapped up its inspection of Emergent’s troubled vaccine manufacturing plant in Baltimore on Tuesday, after halting production there on Monday. By Wednesday morning, the agency already released a series of scathing observations on the cross contamination, sanitary issues and lack of staff training that caused the contract manufacturer to dispose of millions of AstraZeneca and J&J vaccine doses.

Brad Bolzon (Versant)

Ver­sant pulls the wraps off of near­ly $1B in 3 new funds out to build the next fleet of biotech star­tups. And this new gen­er­a­tion is built for speed

Brad Bolzon has an apology to offer by way of introducing a set of 3 new funds that together pack a $950 million wallop in new biotech creation and growth.

“I want to apologize,” says the Versant chairman and managing partner, laughing a little in the intro, “that we don’t have anything fancy or flashy to tell you about our new fund. Same team, around the same amount of capital, same investment strategy. If it ain’t broke, don’t fix it.”

But then there’s the flip side, where everything has changed. Or at least speeded into a relative blur. Here’s Bolzon:

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Bay­er plots a ma­jor facelift at Berke­ley cam­pus, un­cork­ing a 30-year, $1.2B plan to dri­ve cell and gene ther­a­pies

Bayer first set roots in Berkeley back in 1974, when it was still operating as Miles Labs. The site has pumped out three hemophilia A treatments for distribution worldwide; but now, as the pharma continues its cell and gene therapy push, it has something bigger in mind.

Bayer is planning a 30-year revamp at the campus, which includes 918,000 square feet in new buildings and double the jobs, according to a report by the Bay Area Council Economic Institute.

LLS backs 5 new can­cer drug projects with up to $50M; Trodelvy con­tin­ues to im­press with more TNBC da­ta

The Leukemia and Lymphoma Society has tapped 5 new early-stage projects to back with up to $10 million each in fresh investments. The 5 biotechs are:

— Caribou, headed by Rachel Haurwitz and co-founded by Jennifer Doudna, is working on next-gen, off-the-shelf CAR-Ts to replace the patient-derived cells now in use.

— The LLS supported NexImmune’s IPO, helping fund its work on nanoparticles that can gin up an immune response directed at cancer cells. The biotech has 2 projects now in Phase I trials.